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AstraZeneca: Beyond the Science of Pharmacovigilance

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Pascal Soriot, CEO What comes to your mind, if you hear these words, “A bare-knuckle fighter”? May be, ‘Bump and bruises on the cheeks and the hands’ but certainly not a trim frame and well-groomed crown of dark hair, right?

But that is how Pascal Soriot, the CEO of AstraZeneca, and a former bare-knuckle fighter looks like. For a CEO, he can be easily imagined pursuing his weekend pastimes, but rewind 40 years; the young gun was on the gritty housing estate’s backyard where he grew up in the suburbs north of Paris. “I haven’t had a fight in the last 40 years,” he says. “But the first 14, 16 years? I had one probably every week.” This revelation may startle those who know Soriot as a calm and affable presence at the head of the UK-based pharmaceuticals group. Yet he has also demonstrated resilience in building his company to one of the giants in the pharmacovigilance space today.

Soriot has tried to bring some of the Californian spirit to AstraZeneca, where he works in an open-plan office with a framed picture of his grandson on the filing cabinet beside his desk, as he leads his company toward success.

Bridging the Gap between Science and Patient

Testing a potential new medicine in people for the first time is a key moment in drug development. Above all, the treatments being studied can have unpleasant, or even serious, side effects. Often these are temporary and end when the treatment is stopped. Others, however, can be permanent. Some side effects appear during treatment, and others may not show up until after the study is over. The risks depend on the treatment being studied and the health of the people participating in the trial. By improving the design of the early clinical trials and the value of the information they provide, aiming to make better and faster decisions is AstraZeneca. Through its innovative analytics, the company integrates and interprets ‘big data’ from different elements of its clinical trials, from genomic indicators to clinical signs and symptoms and response to treatment and brings its clinical trials to patients such that they can participate in their homes.

Innovative analytics allows AstraZeneca to manage the uncertainty that companies encounter when they first take its drug candidates into patients, and they are contributing to the increased value of all the data we generate, to match the potential drugs to those who are most likely to benefit.

We now know the decision-making criteria for our trials before we even recruit patients, and we have plans in place to adapt over 80 percent of our early phase trials

The company is truly changing the way that the early clinical trials are designed and performed by integrating innovative analytics and aiming to make studies smarter, shorter, smaller and more efficient. “Innovative analytics help us ask questions in our early clinical trials with greater precision, so we can make better decisions. They allow us to use fewer patients and get results sooner, so we can accelerate our most promising agents, which is better for patients and more cost-effective for us,” explains Professor Stephen Rennard, the vice president and head of early clinical development of AstraZeneca.

Soriot says, “AstraZeneca uses previous data and models to predict likely treatment response.” Earlier data analysis assists the company in adapting trials and making important ‘next step’ decisions before trials are completed. The company also incorporates artificial intelligence and machine learning to help them manage, interpret and ultimately integrate high density genomic, clinical and other data. By using real-time data analytics to monitor the safety and effectiveness of the novel candidate treatments and recruiting patients who actively contribute their knowledge and experiences, the company is making its research more flexible for patients, so they can have tests and checkups at local clinics or even at home, instead of traveling to clinical trial centers.

Improving clinical trial design

At the heart of the change in AstraZeneca’s new clinical trial design are advances in its ability to predict the many possible outcomes of the studies and agree how the company will respond to each of these scenarios—before the first patient even sets foot in clinic. “We now know the decision-making criteria for our trials before we even recruit patients, and we have plans in place to adapt over 80 percent of our early phase trials while they are underway, in response to accumulating data. In this way, we only take forward the most promising drug candidates, with the right doses and for the right patients,” says James Matcham, the head of early clinical development biometrics of AstraZeneca.

Being able to adapt the design of early phase trials in response to initial results is a major advantage to researchers as a lack of effectiveness is the most common reason why drugs fail in clinical trials. Thanks to the strength and breadth of AstraZeneca’s pipeline of exploratory agents, the company is increasingly establishing platform studies in its early clinical trials to compare multiple potential drugs for a single disease.

For instance, patients can be recruited to a platform study in cancer or cardiovascular disease according to results of biomarker tests for different sub-types of their disease. Depending on their response to initial treatment, they can move to other drugs on the platform indicated by their disease biomarkers, or stay on their initial drug.

Better Decisions. Better Outcomes.

Further, AstraZeneca also focuses relentlessly in improving the design of its early clinical trials, enhancing its ability to simulate and predict outcomes and rapidly integrating preliminary clinical data to update its models. The company is improving its decision making and enhancing the efficiency of its research continually. To further support rapid, robust decision making in its clinical trials, AstraZeneca employs REACT—REal Time Analytics for Clinical Trials—which is a cutting edge, data crunching system. The system has so far incorporated data from over 200,000 trial participants from some 50 trials in our key therapy areas, helping to support rapid, robust decision making. REACT is a major part of iDecide, the company’s clinical informatics collaboration with Cancer Research UK Manchester Institute, at the University of Manchester and The Christie.

In the latest version of REACT, AstraZeneca has added a new visualisation tool, called Oncoprint, has integrated genomic data from patient tissue and blood samples alongside clinical findings, so that they can dynamically generate and visualise an individual patient or a population genomic profile to understand its significance in the context of their response to therapy. Identifying gene signatures associated with tumour response allows a study to be adapted so the most appropriate patients are included.

En Route to China

Having established themselves in the pharmacovigilance space, AstraZeneca now plans to better employ artificial intelligence, robots, and digital applications to help change disease management in China and transition the drugmaker’s 25-year-old operations in the country toward that of a broader provider of healthcare services. The products could include smarter cancer diagnostics, connected diabetes kits and using AI to improve the transport of patients with chest pain, the report said. While those ventures may not directly raise the company’s drug sales by themselves, it will give AstraZeneca a larger footprint in the Chinese market.

To this end, AstraZeneca has signed two deals earlier this year with Chinese internet conglomerates Alibaba and Tencent. A partnership with Alibaba’s Ali Health will help develop smart health services covering patient education, chronic disease prevention and AI-assisted screening and diagnosis, while the company’s work with Tencent is focused on using big data to combat online sales of counterfeit drugs. “Down the line we benefit, our products benefit, because we have better relationships with doctors and hospital managers and also because we diagnose more patients and they get better treated,” concludes Soriot.